Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT

RCT (n=4088) found after 6.1 years median follow up, 6 months of trastuzumab was non-inferior to 12 months of treatment (4 year disease free survival = 89.5% and 90.3% for 6 and 12 months respectively, HR 1.1, p=0.01 for non-inferiority).

SPS commentary:

Six months’ trastuzumab resulted in fewer patients reporting adverse events of severe grade or stopping early because of cardiotoxicity. Health economic analysis showed that 6 months’ treatment resulted in significantly lower lifetime costs than and similar lifetime quality-adjusted life-years to a 12 months’ course, and thus there is a high probability that the shorter treatment course is cost-effective compared with 12 months treatment.


National Institute for Health Research